a study of neoadjuvant tchpy（pyrotinib ，trastuzumab，carboplatin and paclitaxel）for er+/her2+ breast cancer

Conditions: Breast Cancer; Neoadjuvant

Summary: this study is a multicenter, single-arm, prospective, open clinical study to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and carboplatin in neoadjuvant therapy for er+/her2+ early or locally advanced breast cancer.


Eligibility criteria:
inclusion criteria: * newly treated female patients aged ≥18 years and ≤75 years; * ecog score 0\~1; * pathologically diagnosed as her2-positive breast cancer patients with early or locally advanced tumor stage, primary tumor diameter t≥2cm or lymph node positive; * hormone receptor status (er and pgr) is known, where er≥10% * normal function of major organs: 1. the standard of blood routine examination should meet: anc ≥1.5×109/l; plt≥90×109/l; hb ≥90g/l 2. biochemical examination should meet the following standards: tbil≤ the upper limit of normal value(uln); alt and ast≤1.5 times the upper limit of normal (uln); alkaline phosphatase ≤2.5 times the upper limit of normal (uln); bun and cr≤1.5×uln and creatinine clearance ≥50 ml/min (cockcroftgault formula); 3. cardiac color ultrasound and echocardiography: left ventricular ejection fraction(lvef≥55%) 4. fridericia calibrated qt interval (qtcf) for 18-lead ecg \<470 ms; * for female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment; * volunteer to join the study and sign the informed consent. exclusion criteria: * stage iv (metastatic) breast cancer; * inflammatory breast cancer; * previous antitumor therapy or radiation therapy for any malignancies, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma; * also receiving antitumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy; * had a major surgery not related to breast cancer in the 4 weeks prior to enrollment, or had not fully recovered from such surgery; * serious heart disease or discomfort, including but not limited to the following: * history of heart failure or systolic dysfunction (lvef \< 50%) * high-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \>100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-grade atrioventricular block (i.e. mobitz ii second- degree atrioventricular block or third-degree atrioventricular block * inability to swallow, intestinal obstruction, or other factors affecting the use and absorption of the drug; * known allergic history of the drug components of this protocol; a history of immunodeficiency, including hiv testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; * women who are pregnant or nursing, women who are fertile and have a positive baseline pregnancy test, or women of childbearing age who are unwilling to use effective contraception throughout the trial period and within 7 months after the last study medication; * have a serious concomitant condition or other comorbid condition that interferes with planned treatment, or any other condition in which the investigator deems the patient unsuitable for participation in the study.